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임상시험 NCT07219550은(는) 건강한, 간 기능 장애에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) 1상 58
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임상시험 NCT07219550은(는) 기초과학을(를) 알아보기 위한 연구입니다. 이 연구는 건강한, 간 기능 장애에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 11월 5일에 시작되어 58명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2026년 8월 14일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 5일에 갱신되었습니다.
간단한 개요
The purpose of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tole...더 보기
공식 제목
A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084
질환명
건강한간 기능 장애기타 연구 식별자
- 1084-017
- MK-1084-017 (기타 식별자) (MSD)
NCT 번호
실제 연구 시작일
2025-11-05
최신 업데이트 게시
2026-03-05
예상 연구 완료일
2026-08-14
계획된 등록 인원
58
연구종류
중재연구
단계/상
1상
상태
모집중
주요 목적
기초과학
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Calderasib All participants will receive a single oral dose of calderasib on Day 1. | Calderasib Oral Tablet |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib | Blood samples will be collected to determine the AUC0-last of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Calderasib | Blood samples will be collected to determine the AUC0-inf of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of Calderasib | Blood samples will be collected to determine the AUC0-24 of calderasib in plasma. | Up to approximately 24 hours post-dose |
Maximum Observed Drug Concentration (Cmax) of Calderasib | Blood samples will be collected to determine the Cmax of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
Time to Maximum Observed Drug Concentration (Tmax) of Calderasib | Blood samples will be collected to determine the Tmax of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
Apparent Terminal Half-life (t1/2) of Calderasib | Blood samples will be collected to determine the t1/2 of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
Apparent Clearance (CL/F) of Calderasib | Blood samples will be collected to determine the CL/F of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib | Blood samples will be collected to determine the Vz/F of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants experiencing AEs will be reported. | Up to approximately 14 days |
Number of Participants Who Discontinue Study Due to an AE | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants discontinuing the study due to AEs will be reported. | Up to approximately 14 days |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
All participants:
- Has a body mass index (BMI) between 18.0 and 42.0 kg/m^2
Participants with hepatic impairment (HI):
- Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis
Healthy volunteers:
- Is medically healthy with no clinically significant medical history
All participants:
- Has a history of gastrointestinal disease which may affect food and drug absorption
- Has a history of cancer (malignancy)
- Has a positive result for human immunodeficiency virus (HIV)
- Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
Participants with HI:
- Has had severe complications of liver disease within the preceding 3 months of screening
- Has a history of recent (within 3 months prior to screening) variceal bleeds
- Has evidence of hepatorenal syndrome
- Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of < 3 months
- Has a history of liver or other solid organ transplantation
- Has an active infection requiring systemic therapy
- Requires paracentesis more often than 2 times per month
- Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting
- Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing
- Is using HIV protease inhibitors
- Is positive for Hepatitis B surface antigen (HBsAg)
- Is positive for HCV
Healthy volunteers:
- Has positive results for HBsAg or HCV
연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
3 1개국에 임상시험 장소
Arizona
Arizona Clinical Trials ( Site 0003), Chandler, Arizona, 85225, United States
Study Coordinator, 연락처, 210-253-3426
모집중
Florida
Orlando Clinical Research Center ( Site 0001), Orlando, Florida, 32809, United States
Study Coordinator, 연락처, 407-240-7878
모집중
Texas
The Texas Liver Institute ( Site 0002), San Antonio, Texas, 78215, United States
Study Coordinator, 연락처, 480-470-4000
모집중